Clinical Trial: A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg

Brief Summary: The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]

TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.


Original Primary Outcome: Subjects will complete daily electronic diaries for 4 weeks during the treatment period assessing their allergic rhinitis nasal symptoms.

Current Secondary Outcome:

  • Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.
  • Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.
  • Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.
  • Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.
  • Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.
  • Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.
  • Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing. [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.
  • Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) [ Time Frame: Daily; Baseline through End of Study (Week 4) ]
    The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.
  • Total Ocular Symptoms: Mean Change From Baseline Over the

    Original Secondary Outcome:

    • Subjects will complete daily electronic diaries for 4 weeks during the treatment period assessing their allergic rhinitis ocular symptoms.
    • Mean change from baseline over the entire treatment period in morning (AM), pre-dose, instantaneous total nasal symptom scores (iTNSS)
    • The AM, pre-dose, iTNSS is the sum of the 4 individual nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking their dose
    • Mean change from baseline over the entire treatment period in daily, reflective, total ocular symptom scores (rTOSS)
    • The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness.
    • Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS
    • Mean change from baseline over the entire treatment period in PM rTNSS
    • Mean percent change from baseline over the entire treatment period in daily rTNSS
    • Mean percent change from baseline over the entire treatment period in AM, pre-dose iTNSS
    • Individual Nasal Symptoms:Mean change from baseline over the entire treatment period in individual, daily, reflective, nasal symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing
    • Mean change from baseline over the entire treatment period in individual AM, pre-dose, instantaneous, nasal symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing
    • Mean change from baseline over the entire treatment period in individual, AM, reflective, nasal symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing
    • Mean change from baseline over the entire treatment period in individual, PM, reflective, nasal symptom scores for rhinorrhea, nasal congestion, nasal itching and sneezing
    • Total Ocular Symptoms:Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total ocular symptom scores (iTOSS)
    • Mean change from baseline over the entire treatment period in AM rTOSS
    • Mean change from baseline over the entire treatment period in PM rTOSS
    • Mean percent change from baseline over the entire treatment period in daily rTOSS
    • Mean percent change from baseline over the entire treatment period in AM, pre-dose iTOSS
    • Individual Ocular Symptoms:Mean change from baseline over the entire treatment period in individual, daily, reflective, ocular symptom scores for eye itching/ burning, eye tearing/watering, and eye redness
    • Mean change from baseline over the entire treatment period in individual AM, pre-dose, instantaneous, ocular symptom scores for eye itching/ burning, eye tearing/watering, eye redness
    • Mean change from baseline over the entire treatment period in individual AM, reflective, ocular symptom scores for eyesitching/ burning, eye tearing/watering, eye redness
    • Mean change from baseline over the entire treatment period in individual PM reflective, ocular symptom scores for eye itching/ burning, eye tearing/watering, eye redness
    • Peak Nasal Inspiratory Flow (PNIF):Mean change from baseline over the entire treatment period in daily peak nasal inspiratory flow (PNIF)
    • Mean change from baseline over the entire treatment period in AM peak nasal inspiratory flow
    • Mean change from baseline over the entire treatment period in PM peak nasal inspiratory flow
    • The PNIF is an objective measure of nasal airflow obstruction.


    Information By: GlaxoSmithKline

    Dates:
    Date Received: January 24, 2008
    Date Started: January 2008
    Date Completion:
    Last Updated: November 2, 2016
    Last Verified: November 2016